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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71992-01
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Skin Irritation (2076); Swelling (2091); Skin Inflammation (2443)
Event Date 11/09/2020
Event Type  Injury  
Manufacturer Narrative
The reported product is not expected to be returned as reporter indicated the device was discarded.A follow-up report will be filed if product is returned or additional information is obtained.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer experienced a skin reaction while wearing an adc freestyle libre sensor and experienced symptoms described as swelling and inflammation at the sensor site.Customer had contact with a healthcare professional and received an unspecified ointment for treatment.There was no report of death or permanent injury associated with this event.
 
Event Description
A customer experienced a skin reaction while wearing an adc freestyle libre sensor and experienced symptoms described as swelling and inflammation at the sensor site.Customer had contact with a healthcare professional and received an unspecified ointment for treatment.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned and an extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dhrs (device history review) for the freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.If the product is returned, a physical investigation will be performed and a follow-up report submitted.
 
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Brand Name
FREESTYLE LIBRE 2
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key10862515
MDR Text Key216944435
Report Number2954323-2020-11177
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71992-01
Was Device Available for Evaluation? No
Date Manufacturer Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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